Evidence map›Paper›PMID 31701680›Full record

ArticleESC heart failure2019

Safety of sacubitril/valsartan initiated during hospitalization: data from a non-selected cohort.

Juan Carlos López-Azor, Lourdes Vicent, María Jesús Valero-Masa, Alberto Esteban-Fernández, Manuel Gómez-Bueno, Ángel Pérez, Pablo Díez-Villanueva, Javier De-Juan, Ángel Manuel-Iniesta, Ramón Bover and 2 more

Open access · goldAbstract readMulticenter Study
In one paragraph

Article in ESC heart failure, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 3 pooled it
3.1field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Review
  6. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 2 countries.

Juan Carlos López-AzorServicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Calle Doctor Esquerdo, 46, 28007, Madrid, Spain.
Lourdes VicentServicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Calle Doctor Esquerdo, 46, 28007, Madrid, Spain.
María Jesús Valero-MasaServicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Calle Doctor Esquerdo, 46, 28007, Madrid, Spain.
Alberto Esteban-FernándezServicio de Cardiología, Hospital Universitario de Móstoles, Madrid, Spain.
Manuel Gómez-BuenoServicio de Cardiología, Hospital Universitario Puerta de Hierro, CIBERCV, Madrid, Spain.
Ángel PérezServicio de Cardiología, Hospital de Burgos, Burgos, Spain.
Pablo Díez-VillanuevaServicio de Cardiología, Hospital de La Princesa, Madrid, Spain.
Javier De-JuanServicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain.
Ángel Manuel-IniestaServicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain.
Ramón BoverServicio de Cardiología, Hospital Universitario Clínico de San Carlos. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain.
Susana Del PradoServicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain.
Manuel Martínez-SellésServicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Calle Doctor Esquerdo, 46, 28007, Madrid, Spain.
Centro de Investigación en Red en Enfermedades Cardiovasculares · ESHospital General Universitario Gregorio Marañón · ESHospital Universitario 12 De Octubre · ESHospital Clínico San Carlos · ESHospital Universitario de Burgos · ESHospital Universitario de La Princesa · ESHospital Universitario de Móstoles · ESHospital Universitario La Paz · ESUniversidad Europea · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSacubitril/valsartan is safe when initiated during hospitalization in a clinical trial setting. Its safety in real-life population is not stablished. We compared the initiation of sacubitril/valsartan during hospitalization in a non-selected population, in the PIONEER-HF trial, and in non-selected outpatients. METHODS AND

resultsMulticentre registry included 527 patients: 100 were started on sacubitril/valsartan during hospitalization (19.0%) and 427 as outpatients (81.0%). Compared with those in the pivotal trial, inpatients in our cohort were older (71 ± 12 vs. 61 ± 14 years; P < 0.001); had more frequently Functional Class II (41 [41.0%] vs. 100 [22.7%]; P < 0.001), higher levels of N-terminal pro-B type natriuretic peptide (4044 [1630-8680] vs. 2013 [1002-4132] pg/mL; P < 0.001), better glomerular filtration rate (63.5 [51.0-80.0] vs. 58.4 [47.5-71.5] mL/min; P = 0.01), and higher systolic blood pressure (121 [110-136] vs. 118 [110-133] mmHg; P = 0.03); and received angiotensin-converting enzyme inhibitors/angiotensin receptor blockers more frequently (92 [92.0%] vs. 208 [52.7%]; P < 0.001). Compared with non-selected outpatients, inpatients were older (71 ± 12 vs. 68 ± 12 years, P = 0.02), had more frequent Functional Class III-IV (58 [58.0%] vs. 129 [30.3%], P < 0.001), had higher levels of N-terminal pro-B type natriuretic peptide (4044 [1630-8680] vs. 2182 [1134-4172]; P < 0.001), and were receiving angiotensin-converting enzyme inhibitors/angiotensin receptor blockers target dose less frequently (55 [55.0%] vs. 335 [78.5%]; P < 0.001). They also started sacubitril/valsartan with a low dose (50 mg/12 h) more frequently (80 [80.0%] vs. 209 [48.8%], P < 0.001). The initiation of sacubitril/valsartan in outpatients was an independent predictor of high-dose use (OR 3.1; 95% confidence interval 1.7-5.6, P < 0.001). The follow-up time in both cohorts, including all patients enrolled, was similar (7.0 ± 0.1 vs. 7.2 ± 2.6 months, P = 0.72). All-cause admissions during follow-up were more frequent in inpatients (30 [30.0%] vs. 68 outpatients [15.9%], P = 0.001), with no relevant differences in all-cause mortality. There was no significant difference in sacubitril/valsartan withdrawal rate (17 inpatients [17.0%] vs. 49 outpatients [11.5%], P = 0.13). The incidence of adverse effects was also similar: hypotension (16 inpatients [16.0%] vs. 71 outpatients [16.7%], P = 0.88), worsening renal function (7 inpatients [7.0%] vs. 29 outpatients [6.8%], P = 0.94), and hyperkalaemia (1 inpatient [1.0%] vs. 21 outpatients [4.9%], P = 0.09). We did not register any case of angioedema.

conclusionsIt is safe to initiate sacubitril/valsartan during hospitalization in daily clinical practice. Inpatients have a higher risk profile and receive low starting doses more frequently than outpatients.

Indexed as

AgedAged, 80 and overAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsBlood PressureDrug CombinationsFemaleHeart FailureHospitalizationHumansMaleMiddle AgedProspective StudiesStroke VolumeTetrazolesAminobutyratesAngiotensin Receptor AntagonistsBiphenyl CompoundsDrug Combinationssacubitril and valsartan sodium hydrate drug combinationTetrazolesValsartanHeart failureHospitalizationReduced ejection fractionSacubitril/valsartan

Identifiers

PMID31701680
PMCPMC6989298
OpenAlexW2986500109

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.